EFSA Publishes Opinion on the Safety of Triacylglycerol Lipase Food Enzyme

On July 5, 2024, the European Food Safety Authority (EFSA) issued an official opinion on the safety evaluation of the food enzyme triacylglycerol lipase.

The food enzyme is produced from the non-genetically modified Penicillium caseifulvum strain AE-LRF and manufactured by Amano Enzyme Inc., intended for use in four food production processes. Upon evaluation, the expert panel noted that the estimated total dietary exposure of the European population to the total organic solids (TOS) is up to 0.013 mg TOS/kg body weight (bw) per day under the intended use conditions. Genotoxicity tests did not raise safety concerns. Systemic toxicity was assessed through a 90-day repeated dose oral toxicity study in rats, establishing a no observed adverse effect level (NOAEL) of 69 mg TOS/kg bw/day, resulting in a margin of exposure of at least 5308 compared to the estimated dietary exposure. Additionally, a search for similarities between the amino acid sequence of the food enzyme and known allergens did not identify any matches. However, the expert panel noted that some substances used in the manufacture of the triacylglycerol lipase may leave traces in the food enzyme. Based on the data provided, the expert panel concluded that the risk of allergic reactions upon dietary exposure cannot be fully excluded, particularly in the population allergic to fish, under the intended use conditions. Nevertheless, the panel concluded that the food enzyme is not of safety concern under the intended conditions of use.